Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.

Study Overview

• Status: Recruiting
• Conditions: Acute Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose; Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose; Drug: Miconazole Nitrate 2%

Detailed Description

Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jean-Paul Deslypere, MD; Phone Number: +32492735931; Email: jpdeslypere@aesculape.com

Study Locations

• Belgium
  • Antwerpen, Belgium, 2018
    • Recruiting
    • Dr. Philip Loquet, Private practice - Gynaecology
    • Contact: Philip Loquet, Dr.
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • UZ Antwerpen - Gynaecology department
      • Contact: Gilbert Donders, Prof. Dr.
  • Brabant
    • Tienen, Brabant, Belgium, 3300
      • Recruiting
      • Femicare vzw
      • Contact: Gilbert Donders, Prof. Dr.
  • East Flanders
    • Aalter, East Flanders, Belgium, 9880
      • Recruiting
      • Fertiliteitscentrum Dr. Decleer Aalter
      • Contact: Wim Decleer, MD
    • Gent, East Flanders, Belgium, 9000
      • Recruiting
      • UZ Gent - Gynaecology department
      • Contact: Hans Verstraelen, Prof. Dr.
  • West Flanders
    • Brugge, West Flanders, Belgium, 8000
      • Recruiting
      • Dr. Goessens - Dr. Houben, Private practice - Gynaecology
      • Contact: Luc Goessens, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Main inclusion criteria:

1. Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit.
2. Subjects must have an acute VVC episode at Screening Visit, defined as a total signs and symptoms score of ≥3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.

Main exclusion criteria :

1. Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment.
2. Subjects with visible condylomas on vulvovaginal examination at Screening Visit.
3. Subjects with the presence or a history of another vaginal or vulvar condition(s) that in the Investigator's opinion would confound the interpretation of the clinical response.
4. Subjects with a history of cervical cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream; The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.	Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose; Dosage 1
Experimental: Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream; The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.	Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose; Dosage 2
Active Comparator: Gyno-Daktarin® Vaginal Cream; The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.	Drug: Miconazole Nitrate 2%; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with clinical cure	Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)	First follow-up visit (Day 15)
The proportion of subjects with mycological eradication	A culture negative vaginal swab for growth of baseline Candida species	First follow-up visit (Day 15)
The proportion of subjects with overall therapeutic success	Achievement of both clinical cure and mycological eradication	First follow-up visit (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with clinical cure	Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)	First follow-up visit through Week 12
The proportion of subjects with mycological eradication	A culture negative vaginal swab for growth of baseline Candida species at Day 15, a culture and PCR negative vaginal swab for growth of baseline Candida species on the Other follow-up visits	First follow-up visit through Week 12
The proportion of subjects with overall therapeutic success	Achievement of both clinical cure and mycological eradication	First follow-up visit through Week 12
Change from Baseline in vulvovaginitis symptom questionnaire total score	VSQ: Vulvovaginal symptoms questionnaire	Through Week 12
Change from Baseline in the EQ-5D questionnaire total score	EQ-5D: health-related quality of life questionnaire	Through Week 12

Collaborators and Investigators

• Sponsor: Aesculape CRO Belgium BV
• Investigators: Study Director: Jean-Paul Deslypere, MD, Aesculape CRO Belgium BV

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Anticonvulsants; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole; Bromides
• Other Study ID Numbers: FHP-2021-2-26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No